Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Instituto Nacional de Neurología y Neurocirugía | UNKNOWN |
Not provided
Not provided
Not provided
This Clinical Trial evaluates the nasal administration of Methylprednisolone as a treatment strategy for Acute Relapses in Multiple Sclerosis
This is a prospective, comparative, randomized, double-blind study adhered to the principles established by the Helsinki Declaration, including informed consent. Patients with a diagnosis of Relapsing-Remitting Multiple Sclerosis (RRMS) from the National Institute of Neurology and Neurosurgery (INNN) that are coursing with acute recurrency will be included. The recruited patients will be organized into two paired groups of 40 patients each, of which group 1 will receive 1g IV methylprednisolone, and group 2 will receive the intranasal dose equivalent to 1g of IV methylprednisolone. Clinical symptoms will be measured with the Expanded Disability Status Scale (EDSS) and data will be complemented with results of clinical tests, general laboratories and serum concentration of MP and inflammatory markers. Adverse effects in each group will also be identified and quantified. Statistical analysis: descriptive, assumption of normality, bivariate comparison of means and multivariate, in addition to intention to treat.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Intravenous Methylprednisolone treatment in relapsing-remittent multiple sclerosis | Active Comparator | Intravenous methylprednisolone is the standard treatment for a multiple sclerosis relapse. Thus, 40 randomly enrolled patients aged 18-65 years with relapsing-remitting multiple sclerosis that assist to the hospital and confirmed with a relapse, will be treated with intravenous methylprednisolone, 1000 mg, once a day for 3 days for moderate relapses or 5 days for severe ones. A written informed consent will be obtained from each participant or a legal representative whenever the participant could not provide consent. |
|
| Intranasal Methylprednisolone administration in relapsing-remittent multiple sclerosis | Experimental | Nasal Methylprednisolone Administration For this group, 40 randomly enrolled patients aged 18-65 years with relapsing-remitting multiple sclerosis that assist to the hospital and confirmed with a relapse, will be treated with intranasal methylprednisolone administration (1000 mg once a day for 3 days for moderate relapses or 5 days for severe ones) using a Mucosal Atomization Device (MAD Nasal). A written informed consent will be obtained from each participant or a legal representative whenever the participant could not provide consent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV Methylprednisolone administration | Other | Group 1 will receive 1g methylprednisolone IV for 3 or 5 days, according to the severity of the relapse |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patients' score on the Expanded Disability Status Scale (EDSS) before and after treatment to assess clinical efficacy of treatments |
| Days 0 and 30 after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of inflammatory cytokines and chemokines in peripheral blood before, during, and after treatment | Enzyme-Linked Immunosorbent Assay (ELISA) to detect inflammatory molecules will be performed in plasma derived from blood samples taken from patients prior to treatment, on day 5 of treatment and 30 days after treatment | Days 0, 5 and 30 after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Levels of lymphocyte subsets in peripheral blood before, during, and after treatment | •Flow cytometry will be performed using blood samples taken from patients prior to treatment, on day 5 of treatment and 30 days after treatment | Days 0, 5 and 30 after treatment |
| Shannon and Chao1 indexes in feces samples to determine diversity and composition of intestinal microbiota in patients before and after treatment |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de Neurología y Neurocirugía | Mexico City | 14269 | Mexico |
Information exchange for research purposes
Upon study completion, by request
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 8, 2024 | Jan 8, 2024 |
Not provided
A prospective, comparative, randomized, controlled study in adult patients with confirmed Relapsing-Remitting Multiple Sclerosis that assits to the hospital with an acute relapse.
Not provided
Not provided
Not provided
|
| Nasal Methylprednisolone (MT) | Drug | Group 2 will receive the dose intranasal equivalent to 1g of methylprednisolone for 3 or 5 days according to the severity of the relapse |
|
|
16S rRNA will be sequenced from isolated microbial DNA obtained from patient samples to determine global microbial composition prior to treatment and 30 days after treatment |
| Days 0 and 30 after treatment |
| Number of patients with adverse effects related to the methylprednisolone intranasal treatment as assessed by a questionnaire | • The physician will assess possible adverse effects of the treatment using a questionnaire 30 days after treatment | Day 30 after treatment |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 8, 2024 | Jan 8, 2024 | ICF_001.pdf |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided